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A Study of the Experimental Drug BKM120 With Paclitaxel in Patients With HER2 Negative, Locally Advanced or Metastatic Breast Cancer, With or Without PI3K Activation

Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Breast Cancer

Intervention: Paclitaxel (Drug); BKM120 matching placebo (Drug); BKM120 (Drug)

Phase: Phase 2/Phase 3

Status: Active, not recruiting

Sponsored by: Novartis Pharmaceuticals

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis Pharmaceuticals

Summary

This study will evaluate whether the addition of daily BKM120 to weekly paclitaxel is effective and safe in treating patients with HER2- locally advanced or metastatic breast cancer.

Clinical Details

Official title: A Randomized, Double-blind, Placebo Controlled, Phase II/III Study of BKM120 Plus Paclitaxel in Patients With HER2 Negative Inoperable Locally Advanced or Metastatic Breast Cancer, With or Without PI3K Pathway Activation.

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: progression free survival (PFS)

Secondary outcome:

overall survival

overall response rate

duration of response

time to response

clinical benefit rate

Type, frequency and severity of adverse events

Plasma concentration-time profiles of BKM120 - pharmacokinetics (PK)

Time to definitive deterioration of ECOG performance status

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Breast cancer that is locally advanced or metastatic

- HER2 negative disease, and a known hormone receptor status (common breast cancer

classification tests)

- A tumor sample must be shipped to a central lab for identification of biomarkers

(PI3K activation status) before randomization

- Adequate bone marrow and organ function

- Measurable or non-measurable disease

Exclusion Criteria:

- Prior chemotherapy for locally advanced or metastatic disease

- Previous treatment with PI3K or AKT inhibitors

- Symptomatic brain metastases

- Concurrent malignancy or malignancy within 3 years prior to start of study treatment

- Certain drugs or radiation within 2-4 weeks of enrollment

- Increasing or chronic treatment (> 5 days) with corticosteroids or another

immunosuppressive agent

- Active heart (cardiac) disease as defined in the protocol

- Known hypersensitivity or contraindications to use paclitaxel

- Pregnant or nursing (lactating) woman

- Certain scores on an anxiety and depression mood questionaire given at screening

- Other protocol defined criteria may apply

Locations and Contacts

Novartis Investigative Site, Salzburg 5020, Austria

Novartis Investigative Site, Vienna A-1090, Austria

Novartis Investigative Site, Charleroi 6000, Belgium

Novartis Investigative Site, Liege 4000, Belgium

Novartis Investigative Site, Liège 4000, Belgium

Novartis Investigative Site, Ottignies 1340, Belgium

Novartis Investigative Site, Sint-Niklaas 9100, Belgium

Novartis Investigative Site, Wilrijk 2610, Belgium

Novartis Investigative Site, Brno 656 53, Czech Republic

Novartis Investigative Site, Olomouc 775 20, Czech Republic

Novartis Investigative Site, Praha 2 128 08, Czech Republic

Novartis Investigative Site, Angers Cedex 9 49933, France

Novartis Investigative Site, Bordeaux 33076, France

Novartis Investigative Site, Creteil 94010, France

Novartis Investigative Site, La Roche sur Yon cedex 9 85925, France

Novartis Investigative Site, Le Mans Cedex 72015, France

Novartis Investigative Site, Marseille 13273, France

Novartis Investigative Site, Nice Cedex 2 06189, France

Novartis Investigative Site, Saint Herblain cedex 44805, France

Novartis Investigative Site, Toulouse Cedex 9 31059, France

Novartis Investigative Site, Villejuif Cedex 94805, France

Novartis Investigative Site, Bonn 53111, Germany

Novartis Investigative Site, Dresden 01307, Germany

Novartis Investigative Site, Erlangen 91054, Germany

Novartis Investigative Site, Frankfurt 60389, Germany

Novartis Investigative Site, Fulda 36043, Germany

Novartis Investigative Site, Mainz 55131, Germany

Novartis Investigative Site, Muenchen 80637, Germany

Novartis Investigative Site, Ravensburg 88214, Germany

Novartis Investigative Site, Ulm 89081, Germany

Novartis Investigative Site, Hong Kong SAR, Hong Kong

Novartis Investigative Site, Budapest 1134, Hungary

Novartis Investigative Site, Debrecen 4032, Hungary

Novartis Investigative Site, Szolnok H-5000, Hungary

Novartis Investigative Site, Ramat Gan 52621, Israel

Novartis Investigative Site, Tel-Aviv 64239, Israel

Novartis Investigative Site, Osaka 537-8511, Japan

Novartis Investigative Site, Osaka 540-0006, Japan

Novartis Investigative Site, Seoul 738-736, Korea, Republic of

Novartis Investigative Site, Breda 4819 EV, Netherlands

Novartis Investigative Site, Rotterdam 3075 EA, Netherlands

Novartis Investigative Site, St. Petersburg 197758, Russian Federation

Novartis Investigative Site, Singapore 119228, Singapore

Novartis Investigative Site, Johannesburg 2196, South Africa

Novartis Investigative Site, Madrid 28034, Spain

Novartis Investigative Site, Madrid 28033, Spain

Novartis Investigative Site, Madrid 28040, Spain

Novartis Investigative Site, Madrid 28009, Spain

Novartis Investigative Site, Zaragoza 50009, Spain

Novartis Investigative Site, New Taipei City 23561, Taiwan

Novartis Investigative Site, Taipei 10048, Taiwan

Novartis Investigative Site, Glasgow - Scotland G12 OYN, United Kingdom

Novartis Investigative Site, London, United Kingdom

Novartis Investigative Site, Nottingham NG5 1PB, United Kingdom

Novartis Investigative Site, Rhyl LL18 5UJ, United Kingdom

Novartis Investigative Site, Wirral CH63 3JY, United Kingdom

Novartis Investigative Site, Nagoya-city, Aichi 467-8602, Japan

Novartis Investigative Site, Nagoya, Aichi 464-8681, Japan

Novartis Investigative Site, Cordoba, Andalucia 14004, Spain

Novartis Investigative Site, Malaga, Andalucia 29010, Spain

Novartis Investigative Site, Sevilla, Andalucia 41013, Spain

Ironwood Cancer and Research Centers SC, Chandler, Arizona 85224, United States

Arizona Oncology Associates Dept of Oncology, Phoenix, Arizona, United States

Highlands Oncology Group Dept of Highlands Oncology Grp, Fayetteville, Arkansas 72703, United States

Novartis Investigative Site, Fortaleza, CE 60336-045, Brazil

California Cancer Care Marian Speciality, Greenbrae, California 94904, United States

Novartis Investigative Site, Barcelona, Catalunya 08003, Spain

Novartis Investigative Site, Barcelona, Catalunya 08036, Spain

Novartis Investigative Site, Hospitalet de LLobregat, Catalunya 08907, Spain

Rocky Mountain Cancer Centers RMCC Hale Pkwy, Greenwood Village, Colorado, United States

Novartis Investigative Site, Valencia, Comunidad Valenciana 46010, Spain

Novartis Investigative Site, Valencia, Comunidad Valenciana 46009, Spain

Novartis Investigative Site, Cona, FE 44100, Italy

H. Lee Moffitt Cancer Center & Research Institute SC, Tampa, Florida 33612, United States

Novartis Investigative Site, Genova, GE 16132, Italy

Novartis Investigative Site, A Coruna, Galicia 15009, Spain

Emory University School of Medicine/Winship Cancer Institute Dept.of WinshipCancerInst. (2), Atlanta, Georgia 30322, United States

Northwest Georgia Oncology Center NW Georgia Onc, Marietta, Georgia 30060, United States

Novartis Investigative Site, Sapporo, Hokkaido 135-8550, Japan

Novartis Investigative Site, Isehara-city, Kanagawa 259-1193, Japan

Novartis Investigative Site, Kawasaki-city, Kanagawa 216-8511, Japan

Novartis Investigative Site, Yokohama, Kanagawa 241-8515, Japan

University of Kansas Cancer Center Univ Kansas 2, Kansas City, Kansas 66160, United States

Novartis Investigative Site, Maidstone, Kent M16 9QQ, United Kingdom

Norton Healthcare, Inc., Louisville, Kentucky 40202, United States

Novartis Investigative Site, Seoul, Korea 110 744, Korea, Republic of

Novartis Investigative Site, Seoul, Korea 135-710, Korea, Republic of

Novartis Investigative Site, Kumamoto City, Kumamoto 860-8556, Japan

Novartis Investigative Site, La Laguna, Las Palmas de Gran Canaria 38320, Spain

Novartis Investigative Site, Monza, MB 20900, Italy

Novartis Investigative Site, Messina, ME 98158, Italy

Novartis Investigative Site, Milano, MI 20141, Italy

Washington University School of Medicine Regulatory, St. Louis, Missouri 63110, United States

University of Nebraska Medical Center Unv Nebraska Med Ctr (2), Omaha, Nebraska 68198, United States

University of New Mexico Cancer Research Center Dept of Univ New Mexico, Albuquerque, New Mexico 87131, United States

Novartis Investigative Site, Sydney, New South Wales 2060, Australia

New York Oncology Hematology, P.C. Dept. of New York Oncology. PC, Troy, New York 12180, United States

Ohio State Comprehensive Cancer Center/James Cancer Hospital SC-1, Columbus, Ohio 43210, United States

University of Oklahoma Health Sciences Center OUHSC 2, Oklahoma City, Oklahoma 73104, United States

Northwest Cancer Specialists Vancouver Loc, Portland, Oregon 97210, United States

Novartis Investigative Site, Suita-city, Osaka 565-0871, Japan

Novartis Investigative Site, Montreal, Quebec H3A 1A1, Canada

Novartis Investigative Site, St.- Petersburg, Russia 197022, Russian Federation

Novartis Investigative Site, São Paulo, SP 01221-020, Brazil

Novartis Investigative Site, São Paulo, SP 01246-000, Brazil

Novartis Investigative Site, São Paulo, SP 01317-904, Brazil

Novartis Investigative Site, Kuei-Shan Chiang, Taoyuan/ Taiwan ROC 33305, Taiwan

Baylor Health Care System/Sammons Cancer Center Baylor Texas Oncology, Dallas, Texas 75246, United States

University of Texas Southwestern Medical Center Harry Hines, Dallas, Texas 75390-8527, United States

Cancer Care Centers of South Texas / HOAST CCC of So. TX- San Antonio, San Antonio, Texas 78229, United States

Novartis Investigative Site, Koto, Tokyo 135-8550, Japan

Novartis Investigative Site, Geelong, Victoria 3220, Australia

Novartis Investigative Site, Parkville, Victoria 3050, Australia

Medical Oncology & Hematology Associates of Northern VA Med Onc Hem Northern VA, Reston, Virginia 20190, United States

Novartis Investigative Site, Perth, Western Australia 6005, Australia

Additional Information

Starting date: August 2012
Last updated: November 17, 2014

Page last updated: August 23, 2015

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